At Mumbai, January 10, 2009.

The Third Lecture of the Krishna Raj Memorial was on CliniCal Trials and HealthCare regulation in India.

Speakers:

• Padma Prakash is a trustee of Anusandhan Trust and associated with esocialsciences.
• Amar Jesani is managing trustee of Anusandhan Trust. He is also a member of the editorial board of the Indian Journal of Medical Ethics.
• Annelies den Boer is project coordinator, medicines, WEMOS, Netherlands.
• Sanjay Nagral is former chairperson Forum for Medical Ethics Society and consultant surgeon.
• Sandhya Srinivasan is executive editor, Indian Journal of Medical Ethics and a freelance journalist.
• Soumitra Pathare is a consultant psychiatrist and associated with the Centre for Mental Health Law, Indian Law Society, Pune.
• Urmilla Thatte is head of the department of clinical pharmacology, KEM Hospital, Mumbai, and a member of a number of ethics review committees.
• George Thomas is an orthopaedic surgeon and editor, Indian Journal of Medical Ethics
• Mala Ramanathan is faculty at the Achutha Menon Centre for Health Sciences Studies, Thiruvananthapuran.
• S. Srinivasan (Chinu) is managing trustee of LOCOST (Low Cost Standard Therapeutics), Vadodara, a non profit trust involved in drug manufacturing
• Abhay Shukla is coordinator of SATHI - CEHAT, a centre of Anusandhan Trust.

Co-organised by: Centre for Studies in Ethics and Rights (CSER) and Indian Journal of Medical Ethics (IJME).

Clinical Trials and Healthcare regulation in india. Mumbai: CSER.

This report summarises the presentations and discussions at the seminar. It starts with an overview of ethical concerns in clinical research from the perspectives of Indian activists and those in the West. It then presents the summary findings of an investigation into four trials. Important issues identified in the ensuing discussions are given: the nature of consent from vulnerable groups, the impact of incentives and inducements, and the ethics of placebo controlled trials. The third part of this meeting focused on regulation: in healthcare research, the manufacture of medical devices, and the provision of health services. Presentations were made by a researcher studying ethics committees, a drug manufacturer, and a health activist. Drawing the links between these sections… one can see the interrelatedness of ethics, equity and governance.

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